Principal Medical Device R&D Leader

Cardinal Health, Inc.; Mansfield (MA); On-site; USD 108,000 - 154,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking a Principal Research & Development Engineer to lead design, verification, and lifecycle management of medical device products. You will ensure compliance with FDA/ISO standards and drive product development across cross-functional teams.

In this role you will mentor engineers, influence technical strategy, and contribute to risk management and change control while delivering safe, effective healthcare solutions.

Qualifications

• Bachelor's degree or higher in Biomedical or Mechanical Engineering or related field.
• DFSS certification preferred.
• 4+ years of medical device experience preferred.
• Knowledge of design controls and stage-gate development.
• Knowledge of mechanical systems and injection molding.
• CAD experience, SolidWorks preferred.
• Experience with project management in product development.
• Microsoft Project experience preferred.

Responsibilities

• Lead new product development and sustaining engineering programs for Medical Devices.
• Develop design strategies and incorporate regulatory standards (FDA, ISO, IEC, EN).
• Lead 510k submissions for new products.
• Develop policies and procedures.
• Write and review technical specifications.
• Conduct design reviews and verifications/validations.
• Manage design history and risk management per SOPs.
• Communicate status, risks, and issues to stakeholders.
• Travel to support projects as needed.

Skills

Project management

Cross-functional collaboration

Problem solving

Education

Bachelor’s or higher in Biomedical Engineering, Mechanical Engineering, or related field

Design for Six Sigma (DFSS) Certification

Tools

SolidWorks

Microsoft Project

Job description

Cardinal Health, Inc. is seeking a Principal Research & Development Engineer to lead design, verification, and lifecycle management of medical device products. You will ensure compliance with FDA/ISO standards and drive product development across cross-functional teams.

In this role you will mentor engineers, influence technical strategy, and contribute to risk management and change control while delivering safe, effective healthcare solutions.